Cleared Traditional

K941467 - WOUND DRESSING KIT

K941467 is the FDA 510(k) clearance for WOUND DRESSING KIT by Clinical Resources, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K941467 · Clinical Resources, Inc. · General Hospital
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May 1994
Decision
45d
Days
Class 2
Risk

K941467 is an FDA 510(k) clearance for the WOUND DRESSING KIT. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Resources, Inc. devices

Submission Details

510(k) Number K941467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date May 12, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 102
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